NCT06296082 Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
| NCT ID | NCT06296082 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Universiteit Antwerpen |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-09-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.
Eligibility Criteria
Inclusion Criteria: 1. aged 18-75 years. 2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2). 3. first stroke. 4. 0-12 months evolution. 5. no previous BTX-A or DN treatment for spasticity. 6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°. 7. independent ambulation with or without aids. Exclusion Criteria: 1. medical conditions interfering with data interpretation. 2. contraindications for BTX-A or DN treatment. 3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation. 4. pregnant or breastfeeding.
Contact & Investigator
Pablo Herrero Gallego, PhD
PRINCIPAL INVESTIGATOR
Universidad de Zaragoza
Frequently Asked Questions
Who can join the NCT06296082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06296082 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06296082 currently recruiting?
Yes, NCT06296082 is actively recruiting participants. Contact the research team at pherrero@unizar.es for enrollment information.
Where is the NCT06296082 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Montreal, Canada, Zaragoza, Spain.
Who is sponsoring the NCT06296082 clinical trial?
NCT06296082 is sponsored by Universiteit Antwerpen. The principal investigator is Pablo Herrero Gallego, PhD at Universidad de Zaragoza. The trial plans to enroll 90 participants.
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